中国的Ascletis得到台湾点头干扰素无HCV候选人PHII试用

StephenW

China's Ascletis gets Taiwan nod for PhII trial of interferon-free HCV candidate

China's Ascletis Pharmaceuticals has won approval to begin a Phase II trial of danoprevir (ASC08) in Taiwan in combination with ASC16 (PPI-668) for an interferon-free HCV treatment that could also help put it in pole position in the Chinese market, the company said in a press release.

In June, Ascletis said it had made the clinical trial application in Taiwan following the completion of a successful interferon-containing Phase II trial with ASC08.

The Phase II trial is slated to start in September, while a separate clinical trail application rests with China FDA for review, marking it as the first Chinese company to seek a clinical trial in-country for an interferon-free HCV treatment.

Gilead ($GILD) is still working with Chinese regulators on approval for HCV treatment Sovaldi in China even as a June decision by China's State Intellectual Property Office rejected a portion of an application for the drug. It is also in talks separately with China on possible pricing, the company recently told FiercePharmaAsia.

Ascletis has said it expects an approved drug would compete head-to-head with Sovaldi.

The focus in China for chronic hepatitis C is genotype 1b, experts say, with nearly two-thirds of the 30 million estimated cases in that category. In August, AbbVie ($ABBV) said data on a Viekirax and Exviera cocktail showed a 100% sustained response rate in genotype 1b patients with cirrhosis.

But Ascletis would be the first Chinese-based company to bring a treatment through trials and, if approved, would be a clear leader in the race to bring an approved drug to the market. Danoprevir was licensed for China rights from Roche ($RHHBY) (which halted work in 2013) and ASC16 licensed from Presidio Pharmaceuticals.

China has recently eased multiregional clinical trial hurdles as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market, according to a briefing by the country's State Council.

That may benefit Ascletis, which plans to conduct trials in both Taiwan and mainland China with the company saying in June that Taiwan data may bolster a China approval in early 2016.

Ascletis also has a candidate for the treatment of liver cancer licensed from Alnylam Pharmaceuticals ($ALNY) as well as a candidate licensed from Janssen, ASC09, aimed at HIV.

On Wednesday, Ascletis said it had raised $35 million in a funding round led by C-Bridge Capital, with Tasly Pharma and Singapore-based Pavilion Capital also in the round to fund pipeline expansion, global regulatory filings and GMP-certified manufacturing.

The company was founded in 2011 with $100 million in startup capital and now has four in-licensed candidates.

- here's the clinical trials release (PDF) and the release on the funding round

StephenW

中国的Ascletis得到台湾点头干扰素无HCV候选人PHII试用

中国的Ascletis制药赢得了批准，开始联合danoprevir（ASC08）台湾II期临床试验用ASC16（PPI-668）的干扰素无丙肝的治疗，也有助于把它放在杆位，在中国市场，公司在一份新闻稿中说。

今年六月，Ascletis表示，它已经完成一个成功的含干扰素II期临床试验用ASC08之后由台湾临床试验申请。

在II期临床试验将于9月开始，而一个独立的临床试验应用在于中国FDA的审查，这标志着它作为第一家中国公司，寻求临床试验在国内的干扰素无丙肝治疗。

吉利德（$ GILD）仍在与中国监管机构正在审批丙肝治疗Sovaldi在中国乃至由中国国家知识产权局六月决定拒绝药物应用程序的一部分。也正是在对可能的价格单独会谈，中国，该公司最近告诉FiercePharmaAsia。

Ascletis曾表示，预计批准的药物将角逐头对头Sovaldi。

慢性丙型肝炎在中国的重点是基因1b型，专家说，有近三分之二的该类别3000万估计病例。今年八月，艾伯维（$ ABBV）表示，在Viekirax和Exviera鸡尾酒数据显示，100％的持续应答率1b型肝硬化患者。

但是Ascletis将是第一个中国的公司，通过试验带来了处理，如获批准，将在比赛中带来批准的药物给市场一个明确的领导者。 Danoprevir被授权中国从罗氏（$ RHHBY）（它在2013年停止工作）的权利和ASC16距离Presidio制药许可。

中国最近放宽多区域临床试验的障碍作为努力清除等待，并允许更多的创新疗法，以达到市场的近2万名医药审批申请的一部分，据介绍该国的国务院。

这可能有利于Ascletis，该公司计划与该公司说，在六月，台湾的数据可能会巩固一个中国批准在2016年年初进行的试验在台湾和中国大陆。

Ascletis也对肝癌的治疗从Alnylam制药（$ ALNY）许可，以及来自扬森，ASC09许可的候选人，旨在HIV的候选者。

周三，Ascletis表示，它已经在资助由C-桥资本圆头LED，与天士力制药和新加坡的阁资本也全面资助管道扩展，全球监管机构备案，并GMP认证的生产募集$ 3500万美元。

该公司成立于2011年以$ 1亿美元的启动资金，目前有四个在许可的候选人。

- 这里的临床试验版本（PDF）和上一轮融资发行